NCT00924547

Brief Summary

Oral supplementation of patients affected by cystic fibrosis with docosahexanoic acid (DHA) will result in normalization of the known fatty acid derangements in these patients and will diminish the production of proinflammatory isoprostanes such as 8-isoprostane-PGF2α.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
4.4 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

June 17, 2009

Last Update Submit

July 20, 2015

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisDocosahexanoic AcidDHAisoprostanesfatty acid

Outcome Measures

Primary Outcomes (1)

  • Exhaled breath 8-isoprostane-PGFα and urine 8-isoprostane-PGFα

    4 measurements: baseline and then one measurement after each of the three 4-week study periods

Secondary Outcomes (1)

  • Fatty acid profile analysis including esterification sites in plasma

    4 measurements - Baseline and then one measurement after each of the three 4-week study periods

Study Arms (2)

Docosahexanoic Acid Supplement

EXPERIMENTAL

In this arm, participants took two different doses of a DHA supplement. Each dose of the DHA supplement was taken for 4 weeks.

Dietary Supplement: Docosahexanoic Acid Supplement

Placebo

PLACEBO COMPARATOR

In this arm, participants took a placebo pill that did not contain any DHA.

Dietary Supplement: Placebo

Interventions

Docosahexanoic Acid SupplementDIETARY_SUPPLEMENT

The active treatment will consist of Martek's chewable DHA capsules containing 200mg in each capsule. The treatment will be provided as approximately 25mg/kg/day and 35mg/kg/day. These dosages will be divided BID-TID and will be given for 4 weeks.

Also known as: Martek, DHA
Docosahexanoic Acid Supplement
PlaceboDIETARY_SUPPLEMENT

Placebo identical to active treatment.

Placebo

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Cystic Fibrosis based on sweat chloride value \> 60 mEq/L or genotyping
  • Pancreatic insufficiency, defined by requirement for treatment with exogenous pancreatic enzymes
  • FEV 1 \> 40
  • Less than 3 pulmonary exacerbations in the last year (as diagnosed by pulmonary attending physician)
  • Age greater than 6 years
  • Capability of performing pulmonary function tests
  • Ability to swallow gel capsule
  • Ability to comply with medication use, study visits, and study procedures
  • Written informed consent obtained from subject or study subject's legal representative

You may not qualify if:

  • Presence of severe CF-related liver disease, including SGOT or SGPT\>3 times the normal limits, history of biliary cirrhosis, or portal hypertension
  • Severe pulmonary disease, as defined by FEV1 \< 40%
  • Elevated serum creatinine or BUN
  • Pregnancy
  • PT \>1.5 time normal
  • Diabetes mellitus
  • Daily use of NSAIDs or other anticoagulants
  • History of fish allergy
  • Use of ticlopidine, clopidogrel, dipyridamole
  • Use of glucocorticoids
  • History of lung transplant or currently on lung transplantation list
  • Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Michael G O'Connor, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Pulmonary Fellow

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 19, 2009

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Study Completion

July 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(1)